Rate Of Venous Thromboembolic Events Research Articles

Effect of Comorbidity Burden on the Risk of Venous Thromboembolic Events After Total Knee Arthroplasty.

BackgroundVenous thromboembolic events (VTEs) are common after total knee arthroplasty (TKA). The rate of VTEs has improved with early mobilization, mechanical prophylaxis, and appropriate chemoprophylaxis. The aim of this study was to analyze the contribution of medical comorbidities to the risk of VTE after TKAMethodMedicare claims from 2005 to 2014 were queried. International Classification of Diseases, Ninth revision (ICD-9), and Current Procedural Terminology codes were used to identify the diagnoses, procedures, and complications. 157,200 primary TKAs were age, sex, and Elixhauser Comorbidity Index (ECI) matched with 157,200 osteoarthritis controls. First instances of deep venous thrombosis (DVT) and pulmonary embolism were tracked at 90 days and 2 years. Odds ratios (ORs), confidence intervals, and P-values (p) were calculated and used to investigate the contribution of comorbidities.Results90 days after TKA or OA diagnosis, comorbidities were associated with 45% of the DVT risk, 38% of the PE risk. 1 in 92 patients would be expected to be diagnosed with VTE after TKA and 1 in 136 patients after only the diagnosis of osteoarthritis. After 90 days, medical comorbidities were associated with 70% of the DVT risk, 68% of the PE risk.ConclusionNearly 50% of DVTs and 40% of PEs within 90 days of TKA may be related to the baseline health of OA patients. Venous thromboembolic events after TKA are a “never” event according to Center of Medicare and services that appropriate VTE prophylaxis likely cannot be neutralized.

The association between HIV infection and periprosthetic joint infection following total hip replacement in young adults

ABSTRACT BACKGROUND: The HIV burden in South Africa is high. HIV-positive patients are at risk of developing avascular necrosis of the femoral head, necessitating total hip arthroplasty (THA) at a relatively young age. The primary aim of this study was to investigate the relationship between HIV infection and the risk of periprosthetic joint infection (PJI) in young adults following total hip replacement. Secondly, we aimed to evaluate the association of HIV infection with venous thromboembolic events, reoperation and revision surgery METHODS: We undertook a retrospective cohort study involving patients under the age of 55 years who underwent THA between 2009 and 2016 at a tertiary level arthroplasty unit. In total, 290 cases in 213 patients were analysed, with 77 patients requiring bilateral THA. The median age of patients was 43 years (interquartile range [IQR] 39-48, range 26-54 years). Sixty-two per cent of patients were HIV positive (n=180) with a median CD4 count of 520 cells/mm3 (IQR 423-659, range 238-1308 cells/mm3). Seventy-eight per cent (n=141) of the HIV-positive patients were on antiretroviral medication before surgery. Almost all cases performed in the HIV-positive group were for avascular necrosis (n=178, 99% RESULTS: At a median follow-up of four years (range 2-10) there were no revisions in either group. The incidence of PJI was 1.1% in the HIV-positive group vs 0.9% in the HIV-negative group. The odds ratio for the development of PJI in HIV-positive patients was 1.22 (95% CI 0.11 to 13.67, p=0.869). There was no association between the CD4 count of HIV-positive patients and the development of PJI (p=0.171). There was no difference in the rate of venous thromboembolic events between the HIV-positive and HIV-negative groups (4% vs 6%, p=0.340 CONCLUSION: We report on a cohort of young adult patients who underwent THA. Patients living with HIV infection were not found to be at increased risk for PJI following THA, when compared to HIVnegative patients. The premise that HIV infection increases the risk for PJI following THA remains to be substantiated. This study was underpowered in terms of the primary outcome measure and larger studies are required to verify these findings Level of evidence: Level 4 Keywords: total hip arthroplasty, HIV, AIDS, avascular necrosis, hip, periprosthetic joint infection

Thromboprofilaxys With Fondaparinux vs. Enoxaparin in Hospitalized COVID-19 Patients: A Multicenter Italian Observational Study.

Importance: The use of anticoagulant therapy with heparins decreased mortality in hospitalized patients with severe coronavirus disease 2019 (COVID-19). Even if enoxaparin and fondaparinux have the same clinical indication for venous thromboembolism (VTE) prevention; to date, there are no data about the use of fondaparinux in terms of safety, effectiveness, and impact on clinical prognosis among COVID-19 patients.Objective: To evaluate the safety, effectiveness, and clinical impact of VTE prophylaxis with fondaparinux and enoxaparin among COVID-19 patients hospitalized in internal medicine units.Design, Setting, and Participants: This was a retrospective multicenter observation study, including consecutive symptomatic patients with laboratory-proven COVID-19 admitted to internal medicine units of five Italian hospitals from 15th February to 15th March 2020.Main Outcomes and Measures: The primary safety outcome was the composite of major bleeding and clinically relevant non-major bleeding; the primary effectiveness outcome was the composite of all events classified as pulmonary embolism and deep venous thrombosis. The secondary effectiveness outcome included acute respiratory distress syndrome and all-cause death.Results: Among 120 COVID-19 patients enrolled in the study, 74 were taking enoxaparin (4,000 or 6,000 units/day) and 46 fondaparinux (2.5 units/day). No statistically significant difference in demographic and laboratory and clinical characteristics between the two groups has been shown. During a median follow-up of 32 (interquartile range: 14–51) days, the cumulative incidence rates of VTE and bleeding events on pharmacological thromboprophylaxis with heparins were 19% and 8%, respectively. The incidence of both VTE (6.5 vs. 13.5%; P = 0.36) and bleeding events (6.5 vs. 4.1%; P = 0.68) did not show a significant difference between COVID-19 patients on fondaparinux compared with those on enoxaparin therapy. The regression model for the risk of outcome events according to different VTE prophylaxis drugs did not show significant differences.Conclusions and Relevance: Although these results need confirmation by prospective studies including a larger population, our study provides preliminary evidence of a safe and efficacy use of fondaparinux for VTE prophylaxis in hospitalized COVID-19 patients.

Safety of High-Dose Unfractionated Heparin for Prophylaxis of Venous Thromboembolism in Hospitalized Obese Patients.

Optimal dosing of unfractionated heparin (UFH) for thromboprophylaxis in the obese patient population is uncertain because of their high-risk, prothrombotic state and a complexity of pharmacokinetic considerations. Literature on the appropriateness of the use of a higher dose UFH regimen remains unclear and inconsistent. To evaluate the safety of the use of 7500 units every 8 hours (high-dose) of subcutaneous UFH compared with the use of 5000 units every 8 hours (standard-dose) of subcutaneous UFH for thromboprophylaxis in obese patients (defined as BMI ≥30 kg/m2). In a retrospective cohort study, 326 adult patients were included, with a BMI ≥30 kg/m2, who were admitted to a large, urban academic medical center between September 1, 2015, and September 1, 2018. Patients received either high-dose or standard-dose UFH for at least 48 hours. The primary end point was the incidence rate of bleeding events, defined as a ≥2-g/dL fall in hemoglobin level or receipt of transfusion of 2 or more units of packed red blood cells (pRBCs) from the start of the UFH order. The incidence rate of bleeding was significantly higher in those who received high-dose UFH (43%) compared with those who received standard-dose UFH (29%; P = 0.008). No significant difference was found between venous thromboembolism event rates. High-dose UFH was associated with an increased bleeding event rate compared with standard-dose UFH in patients with a BMI ≥30 kg/m2. This raises safety concerns about the appropriateness of utilizing this regimen in this population.

Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research

ObjectivesReview of efficacy and safety of Janus kinase (JAK) inhibition in immune-mediated inflammatory diseases (IMIDs).MethodsA systematic literature research (SLR) of all publications on JAK inhibitors (JAKi) treatment published until March...

Statins for venous thromboembolism prevention: old dog, new tricks

Abstract Background Statins are highly effective in preventing major acute cardiovascular events in the setting of atherosclerotic arterial disease. On the other hand, given their antithrombotic and anti-inflammatory properties, statins may also attenuate patients' odds of developing venous thromboembolism (VTE). However, clinical studies have yielded variable estimates of this effect. Purpose To perform a meta-analysis designed to evaluate the extent to which statin use influences the rate of subsequent VTE events. Methods We systematically searched MEDLINE, Embase, Web of Science, Cochrane Library and Google Scholar for both randomized controlled trials (RCTs) and observational studies addressing the association between statins and VTE risk, published up until December 1, 2019. Manually reviewed references and key investigators interaction via e-mail correspondence were also data sources. RCTs comparing the effects of statin therapy with those of a placebo or no treatment were included, while interventional studies appraising different lipid-lowering pharmacological strategies were not. Observational studies encompassed both cohort and case-control designs. The primary endpoints were general VTE, deep vein thrombosis or pulmonary embolism. Patients with cancer, heart failure and chronic kidney disease (CKD) were further investigated separately. Study-specific relative risks (RRs) were pooled using generic inverse variance outcome meta-analytic technique with a random-effects model. Results 23 RCTs comprising 118.464 participants, 12 cohort studies encompassing 2.881.184 patients and 9 case-control studies including 354.367 patients were regarded as eligible for quantitative evaluation. Specifically, 5 observational studies comprising 9.656 cancer patients, 3 studies encompassing 9.693 heart failure patients and 4 studies including 4.353 CKD patients were gathered. In RCTs, statin therapy was proven slightly superior to placebo or no treatment in lowering VTE incidence (RR 0.85, 95% CI 0.73–0.99, p=0.04, i2=14%). Observational studies were found to corroborate this effect, with statin treatment resulting in VTE risk reduction overall (RR 0.72, 95% CI 0.64–0.81, p<0.001, i2=84%) and in both cohort (RR 0.86, 95% CI 0.83–0.90, p<0.001, i2=85%) and case-control (RR 0.68, 95% CI 0.57–0.82, p<0.001, i2=80%) designs. This positive effect held true in cancer patients (RR 0.56, 95% CI 0.33–0.95, p=0.03, i2=78%), but not in those with heart failure (RR 0.7, 95% CI 0.42–1.16, p=0.17, i2=2%) and CKD (RR 1.04, 95% CI 0.67–1.60, p=0.87, i2=0%). Conclusion Currently available evidence suggests that statins significantly reduce patients' odds of developing VTE. Given their favorable safety profile and low cost, statin treatment should now be considered in high-risk individuals, particularly in those with cancer. Funding Acknowledgement Type of funding source: None

Patterns and predictors of thromboembolic events among patients with gastric cancer

Patients with gastric cancer are at higher risk for venous thromboembolic events (VTE). Majority of such patients are treated in ambulatory settings where thromboprophylaxis is not routinely offered. In this study, we report on VTE rates and search for predictors that may help identify patients at higher risk to justify VTE-prophylaxis in ambulatory settings. Patients with pathologically-confirmed gastric adenocarcinoma were retrospectively reviewed for VTE detected by imaging studies. Clinical and pathological features known to increase the risk of VTE were studied. Khorana risk assessment model was applied on patients receiving chemotherapy. A total of 671 patients; median age 55 years, were recruited. VTE were diagnosed in 150 (22.4%) patients, including 42 (28.0%) pulmonary embolism and 18 (12.0%) upper extremity deep vein thrombosis (DVT). Majority (> 80%) developed VTE while in ambulatory settings and none had been on thromboprophylaxis. Rate was higher (27.1%) among 365 patients with metastatic compared to 16.7% among 306 patients with nonmetastatic disease, p = 0.001. Patients with metastatic disease who received multiple lines of chemotherapy (n = 85) had significantly higher rate of VTE compared to those who received a single line; 48.2% versus 19.4%, p < 0.001. Among the whole group, Khorana risk score, age, gender, smoking and obesity had no impact on VTE rates. Patients with metastatic gastric cancer, especially when treated with multiple lines of chemotherapy, are at a significantly higher risk of VTE. Khorana risk score had no impact on VTE rates. Thromboprophylaxis in ambulatory patients with metastatic gastric cancer worth studying.

Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme

ObjectivesThis integrated analysis presents the safety profile of upadacitinib, a Janus kinase inhibitor, at 15 mg and 30 mg once daily in patients with moderately to severely active rheumatoid arthritis...

S0655 The Incremental Rate of Thromboembolic Events in Patients With Inflammatory Bowel Disease Compared to Patients Without Immune-Mediated Diseases

INTRODUCTION: This study systematically assessed the incremental risk of thromboembolic events among inflammatory bowel diseases (IBD) patients in the current era where the management of IBD has changed dramatically and several novel IBD agents have been approved. Such an assessment will also serve as a baseline reference for newer agents, such as JAK inhibitors. METHODS: Adult patients with ≥ 2 diagnoses for IBD were identified from the IBM MarketScan Commercial and Medicare-Supplemental Claims database (2014–2018) and matched 1:1 on age, sex, and index year to patients without any immune-mediated diseases (IMD). The outcomes were thromboembolic events (venous: deep vein thrombosis [DVT] and pulmonary embolism [PE]; arterial: myocardial infarction [MI] and ischemic stroke [IS]). To include patients at various stages of IBD disease severity, the index date was the day after a randomly selected IBD medical claim for patients with IBD, and the day after a randomly selected medical claim for patients without IMD. The baseline period was 1-year period prior to the index date, and the study period was the period from index to the end of continuous follow-up (up to 4 years). Multivariable regressions adjusted for age, sex, baseline comorbidities, baseline medications excluding those for IBD, and baseline thromboembolic event of interest. RESULTS: A total of 34,687 matched pairs (mean age 49.0 years, 54.4% female) were included. Patients with IBD generally had higher proportions of comorbidities compared to patients without IMD (e.g., Charlson comorbidity index [0.7 v 0.4]; cardiovascular disease [44.6% v 42.2%]; both P < 0.0001). A significantly higher proportion of patients with IBD had a baseline thromboembolic event compared to patients without IMD (4.7% v 2.6%, P < 0.0001). Patients with IBD experienced higher rates of venous thromboembolic events compared to patients without IMD (Table 1: adjusted incidence rate ratios (IRRs): 2.44 for DVT, 1.90 for PE; both P < 0.0001). Such increased rates were not observed for the arterial events (Table 1: adjusted IRRs: 1.15 for IS, 0.62 for MI). CONCLUSION: Patients with IBD had significantly increased rates of DVT and PE compared to patients without IMD. Increased rates were not observed for IS and MI. This elevated risk should be carefully considered when managing patients with IBD, and the association between IMD treatments and elevated risk of thromboembolic events merits further investigation.Table 1

Coagulation parameters and venous thromboembolism in patients with and without COVID-19 admitted to the Emergency Department for acute respiratory insufficiency

BackgroundIn the recent outbreak of COVID-19 pandemic, increased D-dimer levels and high rates of venous thromboembolic events were reported. We aimed to compare coagulation parameters on admission between COVID-19 patients and non-COVID-19 patients with acute respiratory insufficiency and to describe VTE diagnosed at entry. MethodsIn this single-centre, observational retrospective study consecutive patients admitted for fever and acute respiratory failure were included. Patients underwent laboratory tests, arterial blood gas, chest X-ray, point of care ultrasound (POCUS), limited compression ultrasonography of the lower limbs (L-CUS), chest CT-scan if necessary, and swab test for COVID-19. ResultsOf 324 patients, 50% had COVID-19. COVID19 patients had significantly lower mean white blood cells, neutrophils, platelet count, and pCT values, and significantly higher CRP, LDH, and ferritin levels than non-COVID19 patients. D-dimer was increased in 86.5% COVID19 patients and in 84.9% non-COVID19 patients; mean values were similar (2185 ng/mL and 2814 ng/mL, respectively, p = n.s.). After multivariate analysis, results were unchanged (Odds Ratio 1.00 95%CI: 0.99–1.00, p = 0.21). PT and aPTT values were also similar between the two groups, fibrinogen levels were higher in COVID19 than in non-COVID19 patients (684 and 496 mg/dL, respectively, p < 0.0001). Five patients had asymptomatic proximal deep vein thrombosis detected by L-CUS (3 COVID19) and 2 patients had symptomatic pulmonary embolism (both non-COVID19). ConclusionsD-dimer levels were similarly increased in patients with and without SARS-CoV 2 related disease. There were few cases of asymptomatic deep vein thrombosis or symptomatic pulmonary embolism at first day of admission, similarly distributed between COVID19 patients and non-COVID19 patients.

Association of timing of initiation of pharmacologic venous thromboembolism prophylaxis with outcomes in trauma patients.

Patients are at a high risk for developing venous thromboembolism (VTE) following traumatic injury. We examined the relationship between timing of initiation of pharmacologic prophylaxis with VTE complications. Trauma quality collaborative data from 34 American College of Surgeons Committee on Trauma-verified levels I and II trauma centers were analyzed. Patients were excluded if they were on anticoagulant therapy at the time of injury, had hospitalization <48 hours, or received no or nonstandard pharmacologic VTE prophylaxis (heparin drip). Patient comparison groups were based on timing of initiation of VTE prophylaxis relative to hospital presentation (0 to <24 hours, 24 to <48 hours, ≥48 hours). Risk-adjusted rates of VTE events were calculated accounting for patient factors including type of pharmacologic agent in addition to standard trauma patient confounders. A sensitivity analysis was performed excluding patients who received blood in the first 4 hours and/or patients with a significant traumatic brain injury. Within the 79,386 patients analyzed, there were 1,495 (1.9%) who experienced a VTE complication and 1,437 (1.8%) who died. After adjusting for type of prophylaxis and patient factors, the risk of a VTE event was significantly increased in the 24- to <48-hour (odds ratio, 1.26; 95% confidence interval, 1.09-1.47; p = 0.002) and ≥48-hour (odds ratio, 2.35; 95% confidence interval, 2.04-2.70; p < 0.001) cohorts relative to patients initiated at 0 to <24 hours. These VTE event findings remained significant after exclusion of perceived higher-risk patients in a sensitivity analysis. Early initiation of pharmacologic VTE prophylaxis in stable trauma patients is associated with lower rates of VTE. Diagnostic, level III.

Lower Mortality and Morbidity with Low-Molecular-Weight Heparin for Venous Thromboembolism Prophylaxis in Spine Trauma.

Retrospective review of prospectively collected data. The objective of this study was to evaluate outcomes between patients receiving LMWH versus UH in a retrospective cohort of patients with spine trauma. Although multiple clinical trials have been conducted, current guidelines do not have enough evidence to suggest low-molecular-weight heparin (LMWH) or unfractionated heparin (UH) for venous thromboembolism (VTE) prophylaxis in spine trauma. Patients with spine trauma in the Trauma Quality Improvement Program datasets were identified. Those who died, were transferred within 72 hours, were deemed to have a fatal injury, were discharged within 24 hours, suffered from polytrauma, or were missing data for VTE prophylaxis were excluded. A propensity score was created using age, sex, severity of injury, time to prophylaxis, presence of a cord injury, and altered mental status or hypotension upon arrival, and inverse probability weighted logistic regression modeling was used to evaluate mortality, venous thromboembolic, return to operating room, and total complication rates. E values were used to calculate the likelihood of unmeasured confounders. Those receiving UH (n = 7172) were more severely injured (P < 0.0001), with higher rates of spinal cord injury (32.26% vs. 25.32%, P < 0.0001) and surgical stabilization (29.52% vs. 22.94%, P < 0.0001) compared to those receiving LMWH (n = 20,341). Patients receiving LMWH had lower mortality (odds ratio [OR]: 0.47; 95% CI: 0.42-0.53; P < 0.001; E = 3.68), total complication (OR: 0.92; 95% CI: 0.88-0.95; P < 0.001; E = 1.39), and VTE event (OR: 0.80; 95% CI: 0.72-0.88; P < 0.001; E = 1.81) rates than patients receiving UH. There were no differences in rates of unplanned return to the operating room (OR: 1.01; 95% CI: 0.80-1.27; P = 0.93; E = 1.11). There is an association between lower mortality and receiving LMWH for VTE prophylaxis in patients with spine trauma. A large randomized clinical trial is necessary to confirm these findings. 3.

A meta-analysis of the incidence of venous thromboembolic events and impact of anticoagulation on mortality in patients with COVID-19

BackgroundThe incidence of venous thromboembolic events (VTE) in patients with COVID-19 is generally high but varies markedly. However, the relationship between anticoagulation and mortality in patients with COVID-19 is still unclear. MethodsWe performed a systematic review and meta-analysis to determine the incidence of VTE and evaluate the role of anticoagulation in patients with COVID-19. Random effects models were used to determine overall pooled estimates and 95% confidence intervals (CIs). ResultsAfter a database search, 25 observational studies (20 on VTE incidence and 5 on the relationship between anticoagulation and mortality) were included. The pooled incidence rates of VTE, pulmonary embolism (PE), and deep vein thrombosis (DVT) in hospitalised COVID-19 patients were 21% (95% CI 15–27%), 15% (95% CI 10–20%), and 27% (95% CI 19–36%), respectively. A meta-analysis of five studies found that anticoagulation was not associated with an increased risk of mortality in hospitalised COVID-19 patients (RR = 0.86, 95% CI, 0.69–1.09, P = 0.218; I2 = 47.4%). ConclusionsIn conclusion, the incidence of VTE among hospitalised COVID-19 patients was high. Clinical trials are urgently needed to evaluate the roles of prophylactic and therapeutic anticoagulation in COVID-19.

Venous thromboembolism prevention compliance: A multidisciplinary educational approach utilizing NSQIP best practice guidelines

BackgroundReview of our institutional National Surgical Quality Improvement Project (NSQIP) data found higher rate of Venous Thromboembolic Events (VTE) (2.5% vs. 1.1%). Compared to the national benchmark. Our goal was to identify opportunities for quality improvement. MethodsWe compared NSQIP general surgery data from January 2015–December 2016 (period 1) to January 2017–December 2018 (period 2). A multidisciplinary committee was developed and patient centered education implemented to enhance VTE compliance. ResultsOver 50% of all the patients who developed VTE were non-compliant with chemical prophylaxis. The majority of non-compliance was due to pain. During period 1 there were 12 VTEs in 482 cases, while in period two, 18 VTEs in 2347 cases (2.5% vs. 0.8%; RR 2.3, 95% CI 1.5–3.7, p < 0.001). Missed chemical prophylaxis decreased from 50 to 17 per week after the intervention. ConclusionA multidisciplinary, patient centered approach to increase VTE prevention decreases VTE rates to below a comparable benchmark.

Comparison of venous thromboembolic complications following urological surgery between patients with or without cancer.

Guidelines recommend 4 weeks of thromboembolic prophylaxis in patients who undergo major surgery for solid malignancies. However, there are limited head-to-head comparisons of risk of venous thromboembolic complications in patients with and without cancer undergoing similar surgical procedures. The purpose of this study was to compare risk of venous thromboembolic complications following major renal surgery and cystectomy between patients with and without cancer at the time of surgery. In the nationwide Danish National Patient Registry, which captures all hospital contacts, including surgical procedures, we identified 8,645 patients who underwent major renal surgery (4,273 without cancer and 4,372 with cancer) and 2,164 patients who underwent cystectomy (359 without cancer and 1,805 with cancer) in 2000-2009. The rate of venous thromboembolic events within 6 months from surgery was compared for patients with and without cancer after stratification on organ using Chi-squared test. There was no difference in the rate of venous thromboembolic complications within the first 6 months after major renal surgery (0.4% and 0.3% [p=0.91]) or cystectomy (1.3% and 0.8% [p=0.44]) for patients with and without cancer. The cost for 28 days of Tinzaparin 4.500 IE administered by the patient was €112, whereas the cost if administered by a community nurse was €1.988. Our study questions the different recommendations in thromboembolic prophylaxis between patients with and without cancer after major renal surgery and cystectomy.

Ambulatory Portable Pneumatic Compression Device as Part of a Multimodal Aspirin-Based Approach in Prevention of Venous Thromboembolism in Outpatient Total Knee Arthroplasty.

BackgroundThe purpose of this study is to review the incidence of symptomatic venous thromboembolism (VTE) in patients undergoing outpatient primary total knee arthroplasty (TKA) who used a portable pneumatic compression device as part of their VTE prophylaxis protocol.MethodsA retrospective review of all outpatient primary TKA procedures in which patients used ambulatory pneumatic compression pumps as part of their multimodal VTE prophylaxis was performed from 2016 through 2018. This yielded a cohort of 1131 patients (1453 TKAs). An aspirin (ASA)-based protocol was used in patients with standard VTE risk receiving either 81 mg or 325 mg of ASA twice daily for 6 weeks postoperatively. High-risk patients received a stronger chemoprophylaxis for 2 weeks followed by ASA for 4 weeks. Pneumatic compression pumps were worn for 23 hours/day for 14 days.ResultsVTE prophylaxis medication was 81-mg ASA in 56% of patients, 325-mg ASA in 10% of patients, and stronger chemoprophylaxis in 34% of patients. Patients were considered morbidly obese (body mass index >40 kg/m2) in 267 (18.4%) procedures. Ninety-seven (6.7%) patients had a preoperative history of VTE event. Forty-nine duplex ultrasounds were performed (3.3% of TKAs). Confirmed VTE events were documented in only 5 (0.3%) patients. All VTEs occurred in high-risk patients who were discharged on stronger chemoprophylaxis. The time (days) to VTE was 3, 3, 7, 45, and 88 days.ConclusionThe use of portable pneumatic compression pumps as part of a multimodal VTE prophylaxis protocol aided in a very low rate of symptomatic VTE events in patients undergoing outpatient primary TKA.

Adherence to and persistence with direct oral anticoagulant therapy among patients with new onset venous thromboembolism receiving extended anticoagulant therapy and followed by a centralized anticoagulation service

BackgroundExtended direct oral anticoagulant (DOAC) therapy may be required for patients with a venous thromboembolism (VTE); thus, DOAC adherence may impact the risk of recurrent VTE or bleeding. Materials and methodsThis was a retrospective cohort study. Adult patients with a VTE who were initiated on a DOAC between January 1, 2010 and December 31, 2017 for a cumulative >90 days of therapy were included. Adherence, measured with the proportion of days covered (PDC), was assessed during the six, 12, and 18 months after initiation. Patients were assigned to PDC ≥ 80% (adherent) or PDC < 80% (non-adherent) groups during the 1- to 6-month follow-up period. Rates of recurrent VTE and hemorrhagic events were compared between the groups. ResultsA total of 305 patients were included. The mean PDC were 96.0% (±8.0%), 94.7% (±8.2%), and 94.4% (±7.7%) during the 6-, 12-, and 18-month follow-ups, respectively, with 17 (5.6%) and 288 (94.4%) patients classified as non-adherent and adherent, respectively. Patients in the non-adherent group were more likely to have had a recurrent VTE during the 1- to 6-month (11.8% vs. 1.0%, p = 0.007) and 1- to 12-month follow-ups (16.6% vs. 3.6%, p = 0.030). There were no statistically significant differences between the groups in the rates of bleeding during any follow-up periods (all p > 0.05). ConclusionsIn patients who had >90 days of initial DOAC therapy, adherence to DOAC therapy was high throughout the 18-month follow-up while DOAC non-adherence (i.e., PDC < 80%) increased the risk of recurrent VTE.

Risk of venous thromboembolism in patients receiving neoadjuvant chemotherapy for ovarian cancer.

6073 Background: To identify the incidence of newly occurring venous thromboembolism (VTE) in patients with ovarian cancer receiving neoadjuvant chemotherapy (NACT). Methods: Using our prospectively maintained ovarian cancer database, we identified all ovarian cancer patients who received NACT at our institution from 4/15-9/18. VTE events included clinically diagnosed deep venous thrombosis (DVT) or pulmonary embolism (PE). Patients who presented with VTE prior to induction of NACT or patients on anticoagulation therapy prior to diagnosis were excluded. The incidence of newly occurring thrombotic events were categorized according to treatment phases, defined as 1) NACT prior to interval debulking surgery (IDS); 2) intraoperative and 30-day post-IDS; and 3) adjuvant chemotherapy. Results: 290 patients underwent NACT during the study period. Thirty-eight patients (13%) who presented with VTE, 12 (4%) on anticoagulation at presentation, and 4 (1.4%) seeking only a second opinion were excluded from analysis. Of the 236 evaluable patients, the overall rate of VTE during all treatment phases was 15% (35/236). In treatment phase I, 11% (27/236) of patients experienced VTE during NACT. In phase II, an additional 2.5% (6/236) developed VTE in the intraoperative and 30-day postoperative period. In phase III, an additional 0.8% (2/236) experienced a thrombotic event &gt;30 days postoperatively. Sevety-seven percent (27/35) of VTE events occured during phase I. Conclusions: Patients receiving NACT for advanced ovarian cancer are at high risk for the development of clinically detectable thromboembolic events. The highest rate of new VTE events was seen during induction of NACT, a phase of treatment traditionally without any prophylactic anticoagulation. Further research regarding the timing of thromboprophylaxis for this patient population is warranted. [Table: see text]

Perioperative Use of Antiestrogen Therapies in Breast Reconstruction: A Systematic Review and Treatment Recommendations.

Patients with hormone receptor-positive breast tumors receive hormonal therapy with either selective estrogen receptor modulators (SERMs) (eg, tamoxifen) or aromatase inhibitors (AIs) (eg, anastrozole) for 5 to 10 years. Patients are using these therapies frequently during breast reconstruction. Literature investigating the effects of hormonal modulators on breast reconstruction outcomes demonstrates conflicting results. We sought to perform a systematic evaluation to assess the effects of hormonal therapy on breast reconstruction outcomes and to guide perioperative management of antiestrogen therapies. A MEDLINE, PubMed, and EBSCO Host search of articles regarding the effects of SERMs and AIs on breast reconstruction was performed. Outcomes evaluated included wound complications, total or partial flap loss, and thromboembolic events. Included studies were assigned Methodological Index for Nonrandomized Studies quality scores. A total of 2581 flaps were analyzed for complete loss: patients taking SERMs at the time of reconstruction had higher rates of flap loss compared with patients not taking hormone modulators (P < 0.001). Flap loss was not affected by concurrent AI use (P = 0.11). Both SERMs and AIs had an increased risk of donor site complications (P = 0.0021 and P < 0.0001, respectively). Neither hormone modulator had an effect on flap wound complications or venous thromboembolic event rates. Evidence indicates patients using SERMs at the time of operation are at an increased risk of flap loss and those taking either SERMs or AIs have higher rates of donor site complications. These findings support holding these medications for 1 to 2 half lives (tamoxifen, 14-28 days; AIs, 2-4 days) preoperatively.

High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08

BackgroundHigh rates of venous thromboembolic events (VTEs), mainly in advanced disease, are reported for patients with cancer of the upper gastrointestinal tract (stomach, pancreas) and for treatment with cisplatin.MethodsExploratory analysis of VTEs reported as adverse events and serious adverse events in a prospective, randomised, multicentre, multimodal phase III trial according to VTEs reported as adverse events and severe adverse events. Patients with resectable oesophageal cancer (T2N1–3, T3-4aNx) were randomized to 2 cycles of chemotherapy with docetaxel 75 mg/m2, cisplatin 75 mg/m2 followed by chemo-radiotherapy (CRT) and subsequent surgery (control arm) or the same treatment with addition of cetuximab (investigational arm).ResultsVTEs occurred in 26 of 300 patients included in the trial, resulting in an incidence rate (IR) of 8.7% [95% CI 5.7–12.4%]. A total of 29 VTEs were reported:13 (45%) VTEs were grade 2, 13 (45%) grade 3 and three (10%) fatal grade 5 events. 72% (21/29) of all VTEs occurred preoperatively (IR 6.7%): 14% (4/29) during chemotherapy and 59% (17/29) during CRT. In multivariable logistic regression only adenocarcinoma (IR 11.1%, 21/189 patients) compared to squamous cell cancer (IR 4.5%, 5/111 patients) was significantly associated with VTE-risk during treatment, OR 2.9 [95%CI 1.0–8.4], p = 0.046. Baseline Khorana risk score was 0 in 73% (19/26), 1–2 in 23% (6/26) and 3 in only 4% (1/26) of patients with VTEs.ConclusionA high incidence of VTEs during preoperative therapy of resectable oesophageal cancer is observed in this analysis, especially in patients with adenocarcinoma. The role of prophylactic anticoagulation during neoadjuvant therapy in resectable esophageal cancer should be further evaluated in prospective clinical trials. According to our data, which are in line with other analysis of VTE-risk in patients with oesophageal cancer patients treated with neoadjuvant cisplatin-based chemotherapy and CRT, prophylactic anticoagluation could be considered balanced against individual bleeding risks, especially in patients with adenocarcinoma. In addition to the established risk factors, oesophageal adenocarcinoma treated with neoadjuvant cisplatin-based therapy may be regarded as a high-risk situation for VTEs.Trial registrationRegistered at clinicaltrials.gov,NCT01107639, on 21 April 2010,